Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers
VHTDFU2
Treating Non-healing Foot Wounds With Vaporous Hyperoxia Therapy as an Adjunct to Standard Wound Care
1 other identifier
interventional
30
1 country
3
Brief Summary
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2021
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
December 24, 2019
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2022
CompletedOctober 11, 2021
October 1, 2021
12 months
December 19, 2019
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Wound closure rate at 20 weeks
The percentage of subjects that achieved complete wound closure by week 20, where wound closure is defined by complete re-epithelialization without drainage
20 weeks
Secondary Outcomes (2)
Wound closure rate at 12 weeks
12 weeks
Time to 50%, 75%, 100% wound closure
Up to 20 weeks
Study Arms (1)
VHT treatment
EXPERIMENTALPatients will be treated with VHT for 55 minutes at a minimum frequency of 2 times per week
Interventions
55 minutes of treatment, 2 times per week
Eligibility Criteria
You may qualify if:
- Diabetic foot wound, graded by the Wagner Scale as a 1,2 or 3
- Wound has resisted healing with standard wound care for at least 6 weeks
- No symptoms of sepsis
- Able to maintain reasonable nutrition and hydration
- Able to maintain adequate home care between treatment visits
- Able to understand and follow basic wound care instructions, or has caregiver who can assist
You may not qualify if:
- Skin wounds cancer/neoplastic etiology
- Wounds that involve osteomyelitis or tendon involvement
- Diagnosis of methicillin resistant staph aureus by wound swab
- Acute skin conditions
- Surgery within 30 days of study onset
- Wounds where the end cannot be probed
- Participation in another clinical trial within 120 days prior to study onset
- Non-compliant patients
- Pregnancy
- Presence of co-morbid conditions that in the physician's opinion exclude the individual from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vaporoxlead
Study Sites (3)
Rock Canyon Foot and Ankle Clinic
Castle Rock, Colorado, 80109, United States
Rocky Mountain Foot and Ankle Center
Denver, Colorado, 80033, United States
Colorado Foot and Ankle
Denver, Colorado, 80210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dustin Kruse, DPM
Rocky Mountain Foot and Ankle Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2019
First Posted
December 24, 2019
Study Start
October 4, 2021
Primary Completion
October 3, 2022
Study Completion
October 3, 2022
Last Updated
October 11, 2021
Record last verified: 2021-10